Urinary catheter insertion device and kit

ABSTRACT

A catheter insertion device which employs back-and-forth longitudinal axial movement to advance the catheter by the cooperative interface of an incline ramp and a decline ramp with a split gripping mechanism is described.

TECHNICAL FIELD

The invention described herein is a catheter insertion device and kit,particularly useful with individuals having limited use of theirextremities.

BACKGROUND OF THE INVENTION

A compact urinary catheter is described which is particularly useful forpatients with limited mobility, enabling them to manage self-insertionwith minimal aid from others, recognizing that this is not thesole-intended group, and that all end-users of the device, regardless ofmobility limitations, are included.

SUMMARY OF THE INVENTION

A catheter insertion device is described and which includes variouscomponents: a substantially hollow housing having a longitudinal axis,the housing having a front and a rear and defining at least onelongitudinal slot on a side of the housing; a first ramp positionedtoward a rear of the slot, the first ramp having a decline for downwarddeflection; a second ramp positioned toward a front of the slot, thefirst ramp having an incline for upward deflection; the housing furtherdefining a bottom longitudinal slot. The device will further have anopposed pair of impingement surfaces toward a front of the housing toassist in preventing rearward movement of an inserted catheter tube andan advancing sleeve which is longitudinally insertable along thelongitudinal axis of the housing into at least a portion of the housingfrom the rear, the sleeve movable in a back-and-forth direction alongthe longitudinal axis of the housing, the sleeve having a sleeve top, asleeve bottom, a sleeve front and a sleeve rear.

In one aspect of the invention, the sleeve will comprise: an inwardlyand outwardly deflectable projection at the top front of the sleeve theinward and outward deflection occurring transverse to the longitudinalaxis of the advancing sleeve; a bottom rail on the sleeve configured tofit into the bottom longitudinal slot of the housing; alaterally-extending expanded rear portion configured to stop forwardmovement of the sleeve by impingement upon the rear of the housing; andan opposed pair of gripper or impingement surfaces, at least one of thegripper or impingement surfaces moving interiorly in combination withdownward defecting movement of the projection at the top front of thesleeve upon impingement of the projection with the decline toward therear of the slot and upward deflecting movement of the projection uponimpingement of the projection with the incline toward the front of theslot.

An introducer tip is affixed to the housing at the front; the introducertip having a tip front and a tip rear; and the tip having at least onetransverse slit in the tip front to permit egress of an insertedcatheter.

In one aspect of the invention, the tip will have at least twotransverse slits in the tip spaced apart at approximately 90°.

The deflectable projection at the front of the sleeve is often aperipherally raised region.

The incline for upward deflection is between 1° and 60° inclusive (forsome applications, the incline may be more limited, e.g., between 5° and30° inclusive; and the decline for downward deflection is between 1° and60° inclusive (once again, for some applications, the decline may bemore limited, e.g., between 5° and 30° inclusive.

The advancing mechanism may have an opposed pair of laterally-extendingwings.

The introducing tip will preferably have at least two transverse slits,typically spaced apart at 90°.

The degree of incline and the degree of decline may be the same ordifferent. The front introducer tip front may be selected from the groupconsisting of radiused or cone-shaped.

In one aspect of the invention, the opposed pair of gripper surfaces areessentially semi-circular.

In another aspect of the invention, a catheter insertion kit isdescribed which includes: (1) a catheter; (2) a collection bag; (3) acatheter insertion device, comprising: a substantially hollowcylindrical housing defining a longitudinally extending peripheral sloton one side of the housing; the housing defining an opposedlongitudinally extending groove opposed from the peripheral slot; aforward-projecting cylinder extension in communication with thesubstantially hollow housing; and a means for preventing or retardingrearward motion of the catheter; (5) an advancing mechanism insertableinto the cylindrical housing comprising: a split front pair of opposedsurfaces, at least one of which moves inwardly in response toimpingement of the sleeve with a declining ramp in the housing adjacentthe slot and moves outwardly in response to impingement of the sleevewith an inclining ramp in the housing adjacent the slot; the advancingsleeve having a bottom rail which slidingly engages the longitudinallyextending groove in the housing; the advancing sleeve having an expandedrear portion; (6) an introducer tip having a front and a rear; the rearof the introducer tip matingly engaging with the forward-projectingcylinder extension of the housing; the front of the tip having at leastone transversely extending slit; (7) a front protective cap positionedover at least a portion of the introducer tip; and (8) a rear protectivecap positioned over the expanded rear portion of the advancing sleeve.

The collection bag of the kit is sealed exteriorly about at least aportion of a front circumferential periphery of the housing and aninterior periphery of the expanded rear portion of the advancing sleeve.The collection bag is accordioned rearward of the front circumferentialperiphery of the housing is substantially contained within a cavityformed between the expanded rear portion and the rear protective cap.The catheter is positioned within the advancing sleeve and at least aportion is coiled within the expanded rear portion.

The slope for the inclining ramp for upward deflection is between 1° and60° inclusive and the slope for the declining ramp for downwarddeflection is between 1° and 60° inclusive, although this range may benarrowed for both slopes between 5° and 30° inclusive. The slope for theinclining ramp and the declining ramp may be the same or different. Thesplit front pair of opposed surfaces are essentially semi-circular.

To the accomplishment of the foregoing and related ends the invention,then, comprises the features hereinafter fully described andparticularly pointed out in the claims, the following description andthe annexed drawings setting forth in detail certain illustrativeembodiments of the invention, these being indicative, however, of but afew of the various ways in which the principles of the invention may beemployed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an assembly view in perspective of the component parts of thecatheter insertion device;

FIG. 2 is a perspective view of the device as assembled with catheterbag and catheter sleeve removed, but illustrating a portion of acatheter positioned within the device;

FIG. 3 is a perspective view of the device of FIG. 2 illustrating thecatheter sleeve positioned about the catheter in the initial or first orforwardmost position of the advancing mechanism in the housing withassociated front and rear end caps affixed as well as illustrating therearward extending collection bag, the catheter bag sleeve depicted asaccordioned toward the proximal end of the device;

FIG. 4 is a view similar to FIG. 3 with the collection bag and cathetersleeve in partial cut-away illustrating the catheter in a coiledposition within the collection bag and the advancement mechanism in itsinitial or first or forwardmost position;

FIG. 5 is a view similar to FIG. 4 illustrating the advancementmechanism in its rearward or second position, illustrating thepreviously shown accordion-like folds of the catheter sleeve in theirexpanded form;

FIG. 6 is a cross-sectional side view of the device illustrating theadvancement mechanism in its first or proximal position with portions ofthe catheter sleeve removed for purposes of clarity;

FIG. 7 is an exploded perspective view of the advancement mechanism withcatheter sleeve removed when in its second rearward position with theadvancement mechanism making initial engagement with the catheter byimpingement with a declined ramp in the device housing;

FIG. 8 is an exploded view of the advancement mechanism with cathetersleeve partially removed and the mechanism is in its first position withthe advancement mechanism about to release the catheter;

FIG. 9 is an exploded view similar to FIG. 8 with the advancementmechanism released from the periphery of the catheter;

FIG. 10 is an exploded view similar to FIG. 8 with the advancementmechanism approaching its second rearward position;

FIG. 11 is a partial side elevational view with catheter bag andcatheter bag sleeve removed, but illustrating the catheter positionedwithin the proximal end cap;

FIG. 12 is a partial enlarged perspective view of the accordionedcatheter sleeve within the device but with the advancing mechanism notshown, the device in the proximal or first position, the catheter bagonly partially shown;

FIG. 13 is an enlarged perspective view of FIG. 12 with the device inthe distal or second position;

FIG. 14 is an enlarged side elevational view in partial cross-sectionillustrating one alternative for a rearward retarding mechanism for thecatheter;

FIG. 15 is a top perspective view of the catheter with the advancementmechanism in its second or distal position;

FIG. 16 is a side perspective view of the catheter illustrating theadvancement mechanism in its second or distal position beginning itsimpingement on the decline ramp for at least partial engagement with thecatheter;

FIG. 17 is a top perspective view similar to FIG. 15 illustrating theadvancement mechanism in its first or proximal position, the catheterextending beyond the tip of front cap rod-like tip for a distance “x”;

FIG. 18 is a side perspective view similar to FIG. 17 illustrating theadvancement mechanism in its first or proximal position beginning itsimpingement on the incline ramp for at least partial disengagement withthe catheter; and

FIG. 19A is a perspective view illustrating a circular shape incross-section as an alternative to inverted semicircular shape of uppercatheter tubing guide segment 50;

FIG. 19B is a perspective view illustrating a square or diamond-shape incross-section as an alternative to the inverted semicircular shape ofupper catheter tubing guide segment 50;

FIG. 19C is a perspective view illustrating an grooved triangle orquadrilateral shape in cross-section as an alternative to the invertedsemicircular shape of upper catheter tubing guide segment 50; and

FIG. 19D is a perspective view illustrating a quadrilateral or triangleshape in cross-section as an alternative to the inverted semicircularshape of upper catheter tubing guide segment 50.

DETAILED DESCRIPTION OF THE INVENTION

The present systems and apparatuses and methods are understood morereadily by reference to the following detailed description, examples,drawing, and claims, and their previous and following description.However, before the present devices, systems, and/or methods aredisclosed and described, it is to be understood that this invention isnot limited to the specific devices, systems, and/or methods disclosedunless otherwise specified, as such can, of course, vary. It is also tobe understood that the terminology used herein is for describingparticular aspects only and is not intended to be limiting.

The following description of the invention is provided as an enablingteaching of the invention. To this end, those skilled in the relevantart will recognize and appreciate that many changes can be made to thevarious aspects of the invention described herein, while still obtainingthe beneficial results of the present invention. It will also beapparent that some of the desired benefits of the present invention canbe obtained by selecting some of the features of the present inventionwithout utilizing other features. Accordingly, those who work in the artwill recognize that many modifications and adaptations to the presentinvention are possible and can even be desirable in certaincircumstances and are a part of the present invention. Thus, thefollowing description is provided as illustrative of the principles ofthe present invention and not in limitation thereof.

As used throughout, the singular forms “a,” “an” and “the” includeplural referents unless the context clearly dictates otherwise. Thus,for example, reference to “a” component can include two or more suchcomponents unless the context indicates otherwise. Also, the words“proximal” and “distal” are used to describe items or portions of itemsthat are situated closer to and away from, respectively, a user oroperator such as a surgeon. Thus, for example, the tip or free end of adevice may be referred to as the distal end, whereas the generallyopposing end or handle may be referred to as the proximal end.

Ranges can be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another aspect includes from the one particular value and/orto the other particular value. Similarly, when values are expressed asapproximations, by use of the antecedent “about,” it will be understoodthat the particular value forms another aspect. It will be furtherunderstood that the endpoints of each of the ranges are significant bothin relation to the other endpoint, and independently of the otherendpoint.

As used herein, the terms “optional” or “optionally” mean that thesubsequently described event or circumstance may or may not occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not.

Unless the context clearly indicates otherwise: the word “and” indicatesthe conjunctive; the word “or” indicates the disjunctive; when thearticle is phrased in the disjunctive, followed by the words “or both”or “combinations thereof” both the conjunctive and disjunctive areintended.

As used in this application, the term “approximately” is within 10% ofthe stated value, except where noted.

As used in this application, the term “catheter” includes straight andcoude tip catheters wherein the coude varieties include tiemann tip,tapered tip, and olive tip. Also included are catheters which arepre-lubricated as well as those made from hydrophilic polymers.

As used in this application, the terms “proximal” or “proximate” or“front” refer to locations on the device which is closest to the userwhen the device is in use, while the terms “distal” or “rear” refer tothe location on the device which is farther away from the user duringuse.

In one aspect, as illustrated in FIGS. 1-2, the component parts ofcatheter insertion device 20 include: sleeve housing 22, advancingmechanism 24, introducer tip 26, proximal front cap 28, distal rear cap30, catheter 32 (not drawn to scale) having at least one proximalopening 31 and at least one distal opening 33, catheter bag sleeve 34,and catheter collection bag 36. The device may be used collectively as akit or as a subassembly or as individual component parts.

In an exemplified aspect, sleeve housing 22 is essentially hollow havinga sleeve housing front proximal segment 48 and a sleeve housing reardistal segment 46. At the proximal end of front sleeve housing proximalsegment 48 is male housing circular projection 60 which matingly engageswith the rear cylindrical opening 61 of introducer tip 26. Sleevehousing 22 has an optional handle 38 protruding peripherally from thehousing on one side and an opposed longitudinal sleeve housing slot 42,the details of which are described in more detail below.

Advancing mechanism 24 is insertable into sleeve housing 22 via sleevehousing rear distal segment 46. Advancing mechanism 24 is operativelyconfigured to reciprocate within sleeve housing 22 in a back-and-forthmotion along the longitudinal axis of sleeve housing 22 to advancecatheters 32 (of varying lengths, sizes and compositions as isknown-in-the-art and within the realm of sound engineering judgment) ina manner to be described more fully below. Briefly, top rail 64 willmove longitudinally within sleeve housing 22 as confined within oradjacent sleeve housing slot 42 as well as bottom rail 58 which willmove similarly within bottom slot 65. At the front proximal end of toprail 64 is laterally and peripherally-extending projection 44 to assistin maintaining advancing mechanism 24 within longitudinal slot 42 duringreciprocating back-and-forth longitudinal movement of advancingmechanism 24. Advancing mechanism 24 has a pair of opposed expandeddistal rear sections 40 a, 40 b which limit the forward direction ofadvancing mechanism 24 within sleeve housing 22 by contacting engagementwith rear distal segment 46 of the mechanism. Opposed expanded rearsections are interconnected by catheter tubing guide sleeve 56 at aposition between the front and back sections of the mechanism. Towardthe front or distal end of advancing mechanism 24 is a second cathetertubing guide which is split into two segments 50, 52, (preferablysemicircular although other shapes are envisioned and within the scopeof this invention. Alternative shapes to an inverted semicircular shapeas illustrated in cross-section, would include various shapes incross-section, better illustrated in FIGS. 19A-19D. At least one ofsegments 50, 52 is transversely movable to the longitudinal axis ofadvancing mechanism 24.

As illustrated at least in FIGS. 1-2, rear cylindrical opening 61 ofintroducer tip 26 is matingly engaged with male circular projection 60positioned at the front of housing 22. The mating engagement may befrictional engagement, or may be more permanent (e.g., adhesivelysecured using a permanent, non-permanent or removable adhesive) asend-use applications may demand. At the front of introducer tip ishollow rod-like insertion projection 62 for which at its forward-mostlocation is at least one transverse slit, preferably two or moretransverse slits 67 which permit egress of catheter 32, yet also mayretard rearward movement of the catheter during operation. When twotransverse slits are employed, the slits are generally positioned at 90°from each other. For larger numbers of transverse slits, the preferredgeometry is to employ an equal amount of spacing between thecircumference of the slits, i.e., 360°/n slit segments, a slit segmentdefined as a slit which originates at a circumference and terminates atthe apex of the introducer tip. The shape of the introducer tip may varyin accord with end-user needs and may be radiused or cone-shaped, or anyother geometric shape within sound engineering judgment.

In yet another aspect, front cap 28 is frictionally affixed to tipintroducer 26. The cap may optionally have a loop 66 to assist the userof the device in removing the cap. In operation, this cap is removedprior to beginning insertion of the catheter into a user's urethra.Similarly, rear cap 30 is frictionally affixed to the pair of opposedexpanded rear sections 40 a, 40 b, optionally with a loop 68 to assistthe user of the device in effecting reciprocating movement.

As better illustrated in FIGS. 2 & 6, in one embodiment, sleeve housing22 has at least one pair of opposed impingement surfaces or synonymouslygripper jaws 70 a, 70 b a gap between the jaws or impingement surfacesbeing dimensioned to be slightly less than the outer diameter ofcatheter 32 yet still permitting frictional forward movement of thecatheter. The opposed jaws retard and often prevent, rearward movementof catheter 32 when advancing sleeve mechanism 24 is being retracted toits rearward second or distal position. The interior surface of the jawsmay be straight or curved, and optionally contains a friction-enhancingmechanism, such as a roughened surface or striations to assist inpreventing the catheter tube from reversing direction. While a simplefriction mechanism is shown, other mechanisms are possible, and wouldinclude for example, a rachet and pawl arrangement or a unidirectionalroller or pair of rollers. As better illustrated in FIG. 14, the opposedmechanism may be a pair of circular surfaces 84, shown as non-pivotingin the figure, but with the inclusion of a one-way axis, could be madeto be unidirectional in rotation. While a pair of circular surfaces isillustrated, other options include any impingement surface whichcontacts the exterior outer diameter of catheter 32 and slightlycompresses it. The amount of compression can range from any amountgreater than zero to 50% inclusive, more preferably 0.01 to 25%inclusive, and most preferably 0.1 to 10% inclusive.

In its assembled state as received by a user, distal end 33 of catheter32 has been inserted into the proximal end of catheter bag sleeve 34 andthreaded through catheter bag sleeve 34 and into collection bag 36 asillustrated in FIG. 4. The proximal end of catheter bag sleeve 34 ispositioned within advancement mechanism 24 which is positioned withinhousing 22, at least a portion of the proximal end of the catheter bagsleeve is accordioned 54 (see at least FIGS. 3 & 4) toward the proximalend of the housing when peripherally-extending projection 44 is in itsfirst or proximal position. When peripherally-extending projection 44 isin its rearward or second position, catheter bag sleeve flattens theaccordion design as illustrated in FIG. 5.

FIGS. 7-10 illustrate the use of the reciprocating advancement movement.FIG. 7 illustrates the device with the advancement mechanism in thesecond or distal position. Peripherally-extending projection 44 ispositioned at the rear of sleeve housing 22 and at the rear oflongitudinal slot 42. In this position, transverse projections 76 makecontacting engagement with decline ramps 72 and at least one of thecatheter tubing guide segments (guide segment 50 in the figure) isdepressed into contacting engagement with catheter 32 and at least aportion of lower catheter tubing guide segment 52. In the illustration,upper catheter tubing guide segment 50 is shown contacting the catheterat an angle between 1° and 60° inclusive, although both larger andsmaller declination angles are within the scope of the invention asdetermined by sound engineering judgment. The angle of declination aswell as the length of decline ramp 72 is determined at least in part, bythe amount of compressive force desired by the manufacturer and end-userto facilitate forward movement of catheter 32. Contacting frictional andcompressive engagement of upper and lower catheter tubing guide segments50, 52, are used to advance catheter 32. Catheter advancement iseffected by pushing the distal end of advancing mechanism 24 distal endcaps 40 a, 40 b, inside distal end cap 30, the distance traveled bycatheter 32 being essentially the same as the length of longitudinalslot 42 and illustrated by distance “X” in FIGS. 17-18.

FIG. 8 illustrates the advancement of catheter 32 upon forwardlongitudinal movement of advancement mechanism 24 to a location justprior to completion of the forward movement within longitudinal slot 42.It is noted that upon initial contact with decline ramp 72, the distalend of upper catheter tubing guide segment 50 of advancement mechanism24 is deflected downward to increase the contacting force with catheter32. This increased pressure is maintained for the duration of theforward movement within longitudinal slot 42 and the catheter isadvanced by approximately the length of the slot or the distance “X” inFIGS. 17-18. During this forward movement, catheter bag sleeve 34 isaccordioned toward the front of advancing mechanism 24 within sleevehousing 22 (see accordion-like folds 54). Upon projection 44 reachingthe forward terminus of slot 42, transverse projections 76 ofperipherally extending projection 50, which are resiliently biased tomaintain their original geometry, will move upward, aided by inclineramp 74 (better illustrated in a combination of FIGS. 8-9. Theseparation of split upper and lower tubing guide segments 50, 52 permitsretraction of projection 44 to its rearward distal position withoutcorrespondingly retracting the catheter, aided by the frictionalengagement of jaws 70 a, 70 b, hindering rearward movement of thecatheter tubing, in combination of the at least one transverse slit 67of the hollow rod-like insertion projection 62 of introducer tip 26.Upon peripherally extending projection 44 reaching the rear oflongitudinal slot 42, transverse projections 76 may optionally beextended upwardly for ultimate downward motion as illustrated in FIG. 7.

The angle for upward deflection of incline ramp 74 is between 1° and 60°inclusive; and the decline angle for downward deflection of decline ramp76 is between 1° and 60° inclusive. The deflectable projection has anopposed pair of laterally-extending wings or transverse projections 76.In another embodiment, the incline ramp of the device is more preferablybetween 5° and 30° inclusive, and the decline for downward deflection isbetween 5° and 30° inclusive. It should be noted that the slope and/orangles of the incline and decline ramps may be the same or different.

It should be noted that to maintain the sterility of catheter 32,catheter bag sleeve 34 is sealed exteriorly about at least a portion ofa front circumferential periphery of sleeve housing 22 and also sealedexteriorly about at least a portion of the top and bottom rails ofadvancing mechanism 24. The collection sleeve is compressed in anaccordioned manner 54 about the front circumferential periphery ofsleeve housing 22 when the advancing mechanism is in its proximal orfirst location within longitudinal slot 42 and is in its non-accordionedstate when the advancing mechanism is in its distal location withinlongitudinal slot. Catheter bag sleeve 34 is typically heat sealed toitself on opposed sides 80, as illustrated in FIGS. 12-13. It is alsoadhered to a proximal portion 82 of sleeve housing 22 and to at least aportion 78 of top rail 64 and at least a portion 80 of bottom rail 58.It is this fixed connection that upon reciprocating movement ofadvancing mechanism 24 will accordion the sleeve when the advancingmechanism movement is toward the proximal end or first position (shownin FIG. 12) and will remove the accordion folds of the sleeve when theadvancing mechanism movement is toward the distal end or second position(shown in FIG. 13). It should be noted that when the catheter bag sleeveis sealed as described above, the kit is a closed sterile system to theend-user, minimizing infection risks.

As shown by a combination of FIGS. 15-16 & FIGS. 17-18, and withadvancement mechanism 24 is positioned in its second or distal positionshown in FIGS. 15-16, catheter 32 is not protruding from slits 67 ofrod-like projection 62 of introducer tip 26. Upon continued proximalmovement (better illustrated in FIG. 16), upper catheter tubing guidesegment 50 exerts at least a sufficient amount of compressive force incombination with decline ramps 72 to cooperatively move catheter 32 in aforward direction. Upon peripherally extending projection 44 movingtoward the proximal end of longitudinal slot 42, catheter cooperativelymoves forward by a distance essentially equal to the length of thelongitudinal slot, advancing catheter by approximately a distance “X”illustrated in FIGS. 17-18. The user subsequently moves catheteradvancement mechanism 24 back toward the position illustrated in FIGS.16-17 for a second cycle of operation as described above.

A range of polymers may be used for the construction of the insertiondevice and its component parts, e.g., polyolefins: a non-limiting listincluding at least, polypropylene, polyethylene, low densitypolyethylene; polycarbonates; and polyvinyl chloride or PVC (DEHP-free).

A range of polymers are used for the construction of catheters,including silicone rubber, nylon, polyurethane, polyethyleneterephthalate (PET), latex, and thermoplastic elastomers. Silicone isone of the most common choices because it is inert and unreactive tobody fluids and a range of medical fluids with which it might come intocontact.

At least one important polymeric property for all components of theabove device, is the ability to maintain structural integrity uponexposure to sterilizing radiation, e.g., gamma-radiation.

There are many different types of catheters for bladder problems. Atypical modern intermittent catheter is made from polyurethane and comesin different lengths and sizes for men, women and children. The mostadvanced catheters have a thin hydrophilic surface coating. Whenimmersed in water this coating swells to a smooth, slippery film makingthe catheter safer and more comfortable to insert.

In the foregoing description, certain terms have been used for brevity,clearness and understanding; but no unnecessary limitations are to beimplied therefrom beyond the requirements of the Prior Art, because suchterms are used for descriptive purposes and are intended to be broadlyconstrued. Moreover, the description and illustration of the inventionis by way of example, and the scope of the invention is not limited tothe exact details shown or described.

The best mode for carrying out the invention has been described forpurposes of illustrating the best mode known to the applicant at thetime. The examples are illustrative only and not meant to limit theinvention, as measured by the scope and merit of the claims. Theinvention has been described with reference to, preferred and alternateembodiments. Obviously, modifications and alterations will occur toothers upon the reading and understanding of the specification. It isintended to include all such modifications and alterations insofar asthey come within the scope of the appended claims or the equivalentsthereof.

What is claimed is:
 1. A catheter insertion device which comprises: asubstantially hollow housing having a longitudinal axis, the housinghaving a front and a rear and defining at least one upper longitudinalslot on an exterior of the housing; a first ramp positioned toward arear of the at least one upper longitudinal slot, the first ramp havinga decline for downward deflection; a second ramp positioned toward afront of the at least one upper longitudinal slot, the first ramp havingan incline for upward deflection; the housing further defining a bottomlongitudinal slot; an opposed pair of impingement surfaces toward afront of the housing to assist in preventing rearward movement of aninserted catheter tube; an advancement sleeve longitudinally insertablealong the longitudinal axis of the housing into at least a portion ofthe housing from the rear, the advancement sleeve movable in aback-and-forth direction along the longitudinal axis of the housing, theadvancement sleeve having a sleeve top, a sleeve bottom, a sleeve frontand a sleeve rear; the advancement sleeve comprising: an inwardly andoutwardly deflectable front top rail portion at the top front of thesleeve, the inward and outward deflection occurring transverse to thelongitudinal axis of the advancement sleeve; a bottom rail on theadvancement sleeve configured to fit into the bottom longitudinal slotof the housing; a laterally-extending expanded rear portion configuredto stop forward movement of the advancement sleeve by contactingengagement with the rear of the housing; and an opposed pair of tubingguides, at least one of the tubing guides moving interiorly incombination with downward defecting movement of the top rail uponimpingement of at least a portion of the top rail with the first rampand upward deflecting movement of the top rail upon impingement of atleast a portion of the top rail with the second ramp; an introducer tipaffixed to the housing at the front; the introducer tip having a tipfront and a tip rear; and the tip having at least one transverse slit inthe tip front to permit egress of an inserted catheter.
 2. The device ofclaim 1 wherein the tip further comprises: at least two transverse slitsin the tip spaced apart at approximately 90°.
 3. The device of claim 1wherein the deflectable projection at the front of the sleeve is atransversely extending projection.
 4. The device of claim 1 wherein anincline angle for upward deflection is between 1° and 60° inclusive; anda decline angle for downward deflection is between 1° and 60° inclusive.5. The device of claim 1 wherein the tip has at least two transverseslits.
 6. The device of claim 5 wherein the two transverse slits arespaced apart at 90°.
 7. The device of claim 4 wherein the incline anglefor upward deflection is between 5° and 30° inclusive; and the declineangle for downward deflection is between 5° and 30° inclusive.
 8. Thedevice of claim 1 wherein the angle of incline and the angle of declineare different.
 9. The device of claim 1 wherein the angle of incline andthe angle of decline are the same.
 10. The device of claim 1 wherein theopposed pair of tubing guides are essentially semi-circular.
 11. Acatheter insertion kit which comprises: a collection bag; a catheterinsertion device, comprising: a substantially hollow cylindrical housingdefining a longitudinally extending peripheral slot on one side of thehousing; the housing defining an opposed longitudinally extending grooveopposed from the peripheral slot; a forward-projecting cylinderextension in communication with the substantially hollow housing; and ameans for preventing or retarding rearward motion of the catheter; anadvancing sleeve insertable into the cylindrical housing and having afirst proximal position and a second distal position, comprising: asplit front pair of opposed surfaces, at least one of which movesinwardly in response to impingement of the advancing sleeve with adeclining ramp in the housing adjacent the longitudinally extendingperipheral slot and moves outwardly in response to impingement of theadvancing sleeve with an inclining ramp in the housing adjacent thelongitudinally extending peripheral slot in response to the advancingsleeve moving between the first and second positions; the advancingsleeve having a bottom rail which slidingly engages the longitudinallyextending groove in the housing; the advancing sleeve having an expandedrear portion; a catheter disposed within a collection bag sleeve; thecollection bag sleeve sealed about at least one peripheral edge toitself and to the collection bag; the collection bag sleeve bonded to atleast a portion of a proximal end of the hollow cylindrical housing; thecollection bag sleeve bonded to at least a portion of the top rail ofthe advancing sleeve; the collection bag sleeve bonded to at least aportion of the bottom rail of the advancing sleeve; the collection bagsleeve forming an accordion-like configuration when the advancing sleeveis in the first position; an introducer tip having a front and a rear;the rear of the introducer tip matingly engaging with theforward-projecting cylinder extension of the housing; the front of thetip having at least one transversely extending slit; a front protectivecap positioned over at least a portion of the introducer tip; and a rearprotective cap positioned over the expanded rear portion of theadvancing sleeve.
 12. The kit of claim 11 wherein a slope for theinclining ramp for upward deflection is between 1° and 60° inclusive;and a slope for the declining ramp for downward deflection is between 1°and 60° inclusive.
 13. The kit of claim 12 wherein the slope for theinclining ramp and the declining ramp are the same.
 14. The kit of claim12 wherein the slope for the inclining ramp and the declining ramp aredifferent.
 15. The kit of claim 13 wherein the split front pair ofopposed surfaces are essentially semi-circular.
 16. The kit of claim 11wherein: the rear cap attached to the expanded rear portion of theadvancing sleeve has a loop affixed to a periphery of the rear cap. 17.A catheter insertion device which comprises: a collection bag; acatheter insertion device, comprising: a substantially hollowcylindrical housing defining a longitudinally extending peripheral sloton one side of the housing; the housing defining an opposedlongitudinally extending groove opposed from the peripheral slot; aforward-projecting cylinder extension in communication with thesubstantially hollow housing; and a means for preventing or retardingrearward motion of the catheter; a catheter advancing means insertableinto the cylindrical housing and having a first proximal position and asecond distal position, comprising: a means for effecting transversemovement of at least one component of the catheter advancing means, thetransverse movement effected at least in part to impingement of theadvancing means with a declining ramp in the housing adjacent thelongitudinally extending peripheral slot and moves outwardly in responseto impingement of the advancing means with an inclining ramp in thehousing adjacent the longitudinally extending peripheral slot inresponse to the advancing means moving between the first and secondpositions; a catheter disposed within a collection bag sleeve; thecollection bag sleeve sealed about at least one peripheral edge toitself and to the collection bag; the collection bag sleeve bonded to atleast a portion of a proximal end of the hollow cylindrical housing; thecollection bag sleeve bonded to at least a portion of the top rail ofthe advancing sleeve; the collection bag sleeve bonded to at least aportion of the bottom rail of the advancing sleeve; the collection bagsleeve forming an accordion-like configuration when the advancing sleeveis in the first position; an introducer tip having a front and a rear;the rear of the introducer tip matingly engaging with theforward-projecting cylinder extension of the housing; and the front ofthe tip having at least two transversely extending slits.
 18. The deviceof claim 17 wherein the means for effecting transverse movement of atleast one component of the catheter advancing means is a pair oflaterally extending wings which make contacting engagement with thedeclining and inclining ramps.
 19. The device of claim 18 which furthercomprises: a handle on the substantially hollow cylindrical housing, thehandle positioned opposite the longitudinally extending peripheral slotof the housing.
 20. The device of claim 19 wherein the top rail of theadvancing means rides in the longitudinally extending peripheral slot;and the bottom rail of the advancing means rides in the opposedlongitudinal extending groove opposed from the longitudinally extendingperipheral slot.